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510(k) K925228

IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL by Y — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1993
Date Received
October 16, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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  • K960280 — IVAC NEEDLE FREE VALVE ADMINISTRATION SETS (April 4, 1996)
  • K953225 — IVAC BALL VALCE ADMIN. SETS (September 27, 1995)
  • K934095 — IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS (August 10, 1994)
  • K940897 — IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET (June 22, 1994)
  • K931550 — EZ ADMINISTRATION SET (January 10, 1994)
  • K922115 — IVAC NEEDLELESS INJECTION VALVE (October 12, 1993)
  • K932544 — IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599 (October 12, 1993)
  • K931549 — MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP (October 12, 1993)
  • K930781 — INFUSION PUMP (August 19, 1993)

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